Premature BirthPREMOLFNCT04906577
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
A study testing photography+odour and photography in people with Premature Birth, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- photography+odour and photography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Immediate postpartum mothers of newborns with a term of < 33 weeks (32 weeks + 6 days)
- primiparous mothers
- Mothers with vaginal delivery, without oxytocin infusion after delivery
- Mothers planning to breastfeed, with no maternal contraindication to breastfeeding
Who cannot join
- Substance abuse: active smoking at the time of delivery, alcohol, drugs
- Use of medication: antidepressants or psychotropic drugs or centrally acting anti-emetics
- Active depression or history of depression (under medical care with medical follow-up) in the year preceding the birth, on questioning
- Chromosomal abnormality or congenital malformation of pre- or post-natal diagnosis in the newborn
- Language barrier not allowing proper explanation of the protocol and responses to questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions.
The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother.
The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.
- Conditions
- Premature Birth
- Being tested
- photography+odour, photography
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photography+odourOther
Daily from D0 to D5: a square of cotton cloth will be placed against the child's scalp by the childcare worker in charge of the child, then removed and placed in a sealed box containing a photograph of the child, which will then be given to the mother.
photographyOther
A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.
| Study group | Role | What they receive |
|---|---|---|
| VIZOLF | Experimental | visual stimulus (photograph of the child) and olfactory stimulus ad libitum, with a minimum of 6 stimulations per day, to the body odour emitted by the child during the first 5 days of life Receives: Other: photography+odour |
| VIZ | Experimental | visual stimulus (photograph of the child) and olfactory stimulus ad libitum, with a minimum of 6 stimulations per day, to a neutral odour during the first 5 days of life Receives: Other: photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocytocine levels
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start12 Sep 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Why it stopped: Because of logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence CASAGRANDE, Dr, Study director, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906577
- Sponsor's protocol ID
- 19-PP-05
- Acronym
- PREMOLF
- Status last verified
- Feb 2024
- First submitted
- 25 May 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
- ClinicalTrials.gov ID
- NCT04906577
- Acronym / sponsor ID
- PREMOLF / 19-PP-05
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of logistical problems
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions.
The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother.
The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIZOLF | Experimental | Other: photography+odourvisual stimulus (photograph of the child) and olfactory stimulus ad libitum, with a minimum of 6 stimulations per day, to the body odour emitted by the child during the first 5 days of life |
| VIZ | Experimental | Other: photographyvisual stimulus (photograph of the child) and olfactory stimulus ad libitum, with a minimum of 6 stimulations per day, to a neutral odour during the first 5 days of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Immediate postpartum mothers of newborns with a term of < 33 weeks (32 weeks + 6 days)
- primiparous mothers
- Mothers with vaginal delivery, without oxytocin infusion after delivery
- Mothers planning to breastfeed, with no maternal contraindication to breastfeeding
Key exclusion criteria (5 listed)
- Substance abuse: active smoking at the time of delivery, alcohol, drugs
- Use of medication: antidepressants or psychotropic drugs or centrally acting anti-emetics
- Active depression or history of depression (under medical care with medical follow-up) in the year preceding the birth, on questioning
- Chromosomal abnormality or congenital malformation of pre- or post-natal diagnosis in the newborn
- Language barrier not allowing proper explanation of the protocol and responses to questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photography+odourDaily from D0 to D5: a square of cotton cloth will be placed against the child's scalp by the childcare worker in charge of the child, then removed and placed in a sealed box containing a photograph of the child, which will then be given to the mother. | Other | VIZOLF |
| photographyA neutral smelling cloth will be placed with the child's photograph which will then be given to the mother. | Other | VIZ |
Primary outcome
Change in ocytocine levels
Time frame: Day 4
Results and safety
The study was stopped early (reason given: Because of logistical problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Premature Birth
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence CASAGRANDE, Dr study director
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photography+odour and photography in people with Premature Birth, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of logistical problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ocytocine levels (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.